Eiser C, Davies H, Jenney M, Glaser A
Cancer Research UK Professor of Child Health Psychology, Child and Family Research Group, Department of Psychology, University of Sheffield, Western Bank, UK.
Child Care Health Dev. 2005 Sep;31(5):517-23. doi: 10.1111/j.1365-2214.2005.00538.x.
Survival rates for childhood cancer have improved substantially partly as a result of national and international randomized clinical trials (RCT). However, the decision for families is complex and emotional. Our aim was to describe the views of mothers of children newly diagnosed with ALL regarding consent to randomized controlled trials.
Qualitative interview to explore mothers knowledge, and reasons for involving their child in RCTs. Interviews took place in mothers' homes.
Fifty mothers of children with newly diagnosed ALL (age 4-16 years; mean = 7.4) recruited through research nurses at outpatient appointments.
All but three families had consented for their child to be treated in the RCT, although there was wide variation in their understanding of the aims, costs and benefits. Most mothers reported the aim of the trial to compare 'old' and 'new' treatments.
Despite detailed verbal and written information, mothers were poorly informed about the purpose of the trial, and possibility of side effects. Individual preferences for either standard or new treatment were routinely reported. The data raise questions about the extent to which families give truly informed consent to recruitment of their child to an RCT.
儿童癌症的生存率已大幅提高，部分原因是国内和国际的随机临床试验（RCT）。然而，对家庭来说，这一决定既复杂又情绪化。我们的目的是描述新诊断为急性淋巴细胞白血病（ALL）患儿的母亲对于同意参与随机对照试验的看法。
进行定性访谈，以探究母亲们的认知以及让孩子参与随机对照试验的原因。访谈在母亲家中进行。
通过门诊预约时的研究护士招募了50名新诊断为ALL患儿（年龄4 - 16岁；平均年龄 = 7.4岁）的母亲。
除了三个家庭外，其他所有家庭都同意让孩子参与随机对照试验，尽管她们对试验的目的、成本和益处的理解存在很大差异。大多数母亲表示试验的目的是比较“旧”治疗方法和“新”治疗方法。
尽管提供了详细的口头和书面信息，但母亲们对试验目的和副作用可能性的了解仍然不足。她们经常表达对标准治疗或新治疗的个人偏好。这些数据引发了关于家庭在何种程度上真正知情同意让孩子参与随机对照试验的问题。
